Liver Specialists of Texas: What is Clinical Research

Clinical trials are research studies that test how well new medicines work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in liver clinical trials have an opportunity to contribute to knowledge of, and progress against, all facets of liver disease. Participants also receive up-to-date care from experts. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Studies need volunteers with a certain type of liver disease, including hepatitis C, hepatitis B, ascites, hepatic encephalopathy, or liver cancer. Some studies need healthy people. Others want just men or just women.

People who volunteer for a clinical trial will have the opportunity to have the potential risks, benefits, alternatives, and responsibilities of the clinical trial explained to them before they agree to participate, except in rare circumstances involving emergency procedures in immediate life-threatening situations.

When potential participants feel they understand what is involved with the clinical trial, they indicate their willingness to participate by communicating their agreement and signing a document. This process is called giving consent.

For children or others who are not legally able to provide consent, a parent or legal guardian provides permission for the person to participate. Even though a person may not be legally able to provide consent, they are still informed about the clinical trial to the degree that they are able to understand. They may also have the opportunity to provide their agreement to participate in an alternative way that includes the process of assent.

People usually become aware of the opportunity to participate in a clinical study through:

        Their health care provider
        Public listings of clinical trials (such as clinicaltrials.gov)
        Public notices in print or broadcast media
        Word of mouth

A volunteer for a clinical trial may receive some form of compensation for time and expenses, but not all clinical trials offer compensation.

Current Clinical Trials

Liver Specialists of Texas currently is conducting clinical research studies in the following areas:

1. Chronic hepatitis C
   1. Genotype 1
   2. those never receiving treatment previously
2. Hepatic encephalopathy
   1. Mild to moderate confusion related to cirrhosis
3. Ascites
   1. fluid accumulation in the abdomen in patients with cirrhosis
   2. patient must have undergone a recent paracentesis

In 2008, we will be participating in studies investigating new therapies for hepatitis C and hepatitis B, as well as a protocol investigating protease inhibitors in patients with hepatitis C previously treated and who failed therapy.

Contact our office if you are interested in current or future research therapies.

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